Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries (PTSD-TBI)

January 30, 2017 updated by: Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies

Evaluation of the Effectiveness of a Novel Brain and Vestibular Rehabilitation Treatment Modality in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries

Treatment for veterans who have had a traumatic brain injury (TBI) and who are suffering from post traumatic stress syndrome (PTSD) is varied with varied outcomes. Investigators will study PTSD treatment in military Veterans who have suffered traumatic brain injuries. Investigators will use 1 independent specialty treatment centers that utilize a specific novel methodology of PTSD treatments and study the clinical outcomes of veterans who have suffered a TBI with associated post-concussive symptoms and other comorbidities such as PTSD. Investigators hypothesize that the treatment of PTSD will have a significant outcome with neurological physical and vestibular rehabilitation when compared to psychological or psychiatric therapy. This study will use gold standard measurement scales and compare changes in the scales after treatment to evaluate the treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Department of Defense and the Defense and Veteran's Brain Injury Center estimate that 22% of all combat casualties from conflicts in Iraq and Afghanistan are brain injuries. Patients with TBI often meet criteria for PTSD on screening instruments for TBI and vice versa. No screening instruments available can reliably make the diagnosis of PTSD and the gold standard remains an interview by a skilled clinician using the Clinician-Administered PTSD Scale (CAPS) a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for PTSD. Treatment for veterans who have had a TBI and who are suffering from PTSD is varied with varied outcomes. Investigators propose a Randomized Prospective Clinical Trial of PTSD treatment in military Veterans that have suffered traumatic brain injuries. Investigators will use 2 independent specialty treatment centers that utilize different methodology of PTSD treatments and study the clinical outcomes of veterans who have suffered a TBI with associated post-concussive symptoms and other comorbidities such as PTSD. This study will use a baseline CAPS assessment and investigators will establish cut points and randomize from within those to establish a stratified randomization within groups. Subjects will undergo treatments and an outcome CAPS score will be obtained at the end of treatment as the primary outcome to calculate if there is a change in score that is statistically or clinically significant. Investigators also will utilize secondary outcomes to measure any changes in the scores obtained by these instruments. These instruments and measures such as Computerized Dynamic Posturography and video electronystagmography and saccadometry will be obtained before the initiation of treatment and when treatment is terminated to measure a change in score. All instruments will be used to measure changes in function that are related to changes in PTSD symptomatology and neurological function

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Irving, Texas, United States, 75062
        • Carrick Brain Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of PTSD
  • History of Traumatic Brain Injury
  • Military veteran of conflict in war zone

Exclusion Criteria:

  • Criminal history of violence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional Neurological Rehabilitation
Functional Neurological and physical/vestibular rehabilitation strategies
Procedure: Functional Neurological Rehabilitation
Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Diagnostic and Statistical Manual of Mental Disorders IV Clinician-Administered PTSD Scale DSM IV-(CAPS)
Time Frame: up to 12 weeks
The CAPS is the gold standard in PTSD assessment and is a 30-item structured interview.For each symptom, standardized questions and probes are provided. Administration requires identification of an index traumatic event to serve as the basis for symptom inquiry. The full interview takes 45-60 minutes to administer.CAPS symptom severity ratings are based on symptom frequency and intensity (except for amnesia and diminished interest which are based on amount and intensity). Higher scores represent a worse outcome with severity categories of 0-19 (minimal), 20-39 (mild), 40-59 (moderate), 60-79 (severe), 80-136 (extreme). We will use changes in the DSM-IV CAPS scores before and after treatment to distinguish between the estimated frequency and intensity of the various symptoms. Frequency and intensity scores will be combined to give a total CAPS score (range: 0-136) CAPS testing was scheduled pre-intervention, 1 week post-intervention, and at 3 months post-intervention.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carrick Institute for Graduate Studies

Collaborators

Carrick Brain Centers

Investigators

  • Principal Investigator: Frederick R Carrick, PhD, Carrick IGS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

December 2, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBC11013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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